ANZCTR search results

The objective of the study is to determine if a predefined quotient of supplementary language exposure improves short, intermediate and long-term neurodevelopmental outcomes in preterm infants (<30 weeks) cared for in the neonatal unit. Participants <30 weeks gestational age, admitted to the Neonatal Intensive Care Unit, will be randomised to receive either one of two levels of supplemental language exposure in the form of recorded maternal voice, delivered via micro speaker. The intervention group will receive a treatment level of exposure of 6000 words/hour and the control group will receive a placebo of 600 words/hour within a developmental appropriate decibel range. The exposure will occur for one hour, three times daily, commencing on day 7 of life until 37 weeks gestational age or discharge. The level of 6000 words was chosen as the rate of slow speech is approximately 100 words/minute. Mothers of participants included in the trial will be directed to speak in 'motherese' style language at this rate for ten minutes. The recording will then be repeated six times. Control group infants will receive 10% of the language exposure level of the intervention group.

Airway or respiratory complication is one of leading causes of morbidity and mortality in anaesthesia. There are different techniques and intubating equipment (laryngoscope) available for anaesthetists to deal withdifficult airways. Anaesthetists use their knowledge and previous experience to decide which type of laryngoscope to use in these cases. In this study, we are evaluating, for the first time, this newly available videolaryngoscope. We are comparing it with the widely used Glidescope® video laryngoscope. The reason for comparing these two devices is because the blade design of both devices is similar. We hypothesise that In simulated difficult airways, the novel videolaryngoscope allows a faster tracheal intubation time as compared to the Glidescope® video laryngoscope. We will prospectively recruit 30 voluntary anaesthetic residents, registrars or consultants for this study. All participants will be tested on using each of the two intubation devices on a manikin with a simulated difficult airway. Participants will be assigned to one of the two groups – Group 1: novel videolaryngoscope followed by Glidescope® videolaryngoscope, or Group 2: Glidescope® videolaryngoscope followed by novel videolaryngoscope. The primary outcome is the time taken for successful tracheal intubation. Secondary outcomes include: the number of failed intubation, the number of intubation attempts, the number and type of intubating adjuncts used, the best laryngoscopy view achieved and the ease of intubation.

The current study is a prospective cohort study that will test the feasibility and acceptability of heat wrap therapy as well as our ability to collect the key outcomes planned for the RCT, which are use of analgesic medications, clinical outcomes (such as pain, function), and adverse events.

The primary aim of this study is to determine if short-term regular apple intake (4 weeks) results in a sustained benefit on measures of vascular health in individuals with at least one risk factor for cardiovascular disease.

‘Agents of Change’ is a new collaborative research project funded by the NHMRC Boosting Dementia Research Grants and NHMRC Cognitive Decline Partnership Centre. The project aims to improve the implementation of three key recommendations from the Clinical Practice Guidelines for Dementia in Australia: 1. ‘People living in the community should be offered occupational therapy (reflecting evidence based programs)’ 2. ‘People with dementia should be strongly encouraged to exercise’ 3. ‘Carers and family should have access to programs to support and optimise their ability to provide care for the person with dementia’ This will be achieved by establishing a national quality collaborative in which health professionals across Australia are trained and supported to develop and enact an implementation plan addressing one of the recommendations. Health professionals (e.g. general practitioners, nurses, social workers, occupational therapists, physiotherapists, psychologists) who regularly provide services to people with dementia, and who have some influence in their workplace to affect change will act as implementation clinicians. Implementation clinicians will be trained and supported to develop and then enact an implementation plan tailored to their recommendation of interest. They will participate in an online training course about quality improvement and translating research evidence into practice. In addition to the online training and tools, Implementation clinicians will be supported by a team of clinical, consumer and quality improvement experts to develop their unique implementation plan. They will have regular opportunities to have online communication with their collaborative. The primary outcome of this project is to measure the number of people living with dementia receiving the recommended level of care (consistent with the implementation plan). The feasibility of establishing national quality collaborative will also be explored. Interest and participation in the program will be assessed and feedback about the success of plans and barriers to implementation from clinicians and the people with dementia they are supporting will be gathered.

This study will evaluate the effectiveness of targeted screening of people at high-risk of melanoma using 3D full body imaging and genomic risk assessment. Who is it for? You may be eligible to join this study if you have been diagnosed with melanoma before the age of 40 years old. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive standard care at the participants’ discretion which may involve regular skin checks from their own doctor. Participants in the other group will attend a screening program involving 6-monthly 3D full body imaging for 24 months and a once-off genetic testing for high-risk melanoma genes. We hypothesise our surveillance program using 3D whole body photography and genomic testing will be cost-effective, and will result in fewer excisions of benign lesions and earlier/smaller excision of malignant lesions than the control standard care group

Due to high susceptibility to infections, antibiotics are the most widely used drugs for newborns. Recent evidence suggests that antibiotics exposure in newborn period (first 4 weeks of life) predisposes to an imbalance in the gut, which may have long lasting consequences. Imbalances in the infants’ gut bacteria (microbiome) caused by antibiotics has been shown to alter the development of the neonate’s immune response. This altered immune development caused by a poorly balanced microbiome during this crucial phase of early life has been associated with the development of atopy, asthma, eczema, allergy, type 1 diabetes and inflammatory bowel disease. Mucosal immunity development in the gut has been shown to be aberrant as early as one month of age in children who go on to develop allergy symptoms in future. RESTORE is a clinical trial of a multi-strain probiotic for antibiotics exposed term newborn infants with aims to restore biodiversity and reduce dysbiosis (imbalance of bacteria) in the newborn gut in early months after birth. This is the first study of its kind to examine effects of probiotics on these high-risk infants’ gut biodiversity and mucosal immune development. Research Questions 1. Can the gut microbial diversity of infants exposed to postnatal antibiotics be restored earlier (within neonatal period after birth) by daily use of multi-strain probiotic supplementation? 2. Is this effect sustained at 3 months and 12 months? 3. Can probiotics in antibiotic exposed infants improve the production of salivary and secretory IgA to that seen in infants without antibiotics exposure? Methodology This randomised control trial will be conducted at Fiona Stanley Hospital. A total of 120 term neonates will be recruited, 80 of whom would have received antibiotics at birth for clinical reasons. Forty of the antibiotic exposed neonates will receive daily probiotics for 3 months and forty infants will receive a placebo. Forty infants without antibiotic exposure will serve as a reference group. Stool, saliva and blood will collected for microbiome and/or immunological tests at five time-points in the first 12 months of life. Predicted Benefits and Relevance: Neonatal infections, antibiotic use and allergy in later life are highly relevant health issues for infants, with gut microbiome as the potential denominator. In Australia, the economic cost of allergic diseases is estimated to be >$30 billion annually. Probiotics have been extensively used to restore microbiome balance in adults and hold potential to be useful for newborns for this indication. Although some promising data exists from animal studies, No human studies have yet determined whether probiotics are effective in rapidly restoring the balance of bacteria in term neonates’ gut following exposure to antibiotics. We are proposing a randomised control trial to determine if multi-strain probiotics can rapidly normalize the infants’ microbiome following neonatal antibiotic exposure during the crucial time of immune development and improve mucosal immunity. This study will provide insights for conducting larger multicentre trial to confirm clinical benefits; which will potentially change the practice to routinely supplement these high-risk babies with probiotics in the newborn period.

The aim of the project is to evaluate the risk of antibodies to blood donor proteins developing after blood transfusions from blood donors selected to be compatible with the recipient. Participants will be patients who are planned to undergo a kidney transplant with a live donor. Testing for antibodies to donor proteins will be done before and 6-8 weeks after the transfusion to look for the development of new antibodies. This will help researchers to find a way to give patients blood transfusions without the risk of them developing antibodies that could put later transplants at risk.

The Harmony in the Bush dementia study will implement innovative strategies of an individualised care model developed based on the principles of a well-established Progressively Lowered Stress Threshold (PLST) framework for non-pharmacological care of dementia. The PLST model recognises that behavioural and psychological symptoms of dementia, such as agitation, are experienced by people with dementia and increased stress is triggered by internal and external environmental factors. These factors will be identified during the assessment phase of this research intervention, and the investigators will work with the residential aged care staff to help them modify the daily routine and implement more flexible, personalised activities of daily living including sleep. Actigraphy watches will be fitted on the wrists of participating residents living with dementia to record the sleep patterns. Collectively, these information will be used in co-designing personalised care plans based on the PLST model seven principles .This research will also expand the PLST-based personalised care model intervention, by incorporating individualised preferred music/arts and movement programs to co-design a PLST plus music/arts and movement personalised care intervention. The investigators hypothesise that these co-designed PLST-based (without and with integrated individualised preferred music/arts activities) personalised care interventions will result in a low stress organisational environment and a positive workplace culture; thus leading to improved residents with dementia outcomes such as reduced agitation level, better quality sleep and overall wellbeing, reduced caregivers stress level, and a positive change in the workplace culture.

This study will evaluate the effectiveness of using activity monitors to assess pain and physical activity in patients with advanced cancer. Who is it for? To be eligible for the study participants are to be over the age of 18 years, diagnosed with advanced cancer, are experiencing pain, and are patients at Mater Misericordaie Ltd or St Vincent's Private Hospital, Brisbane. Study Details: Participants will receive an tri- accelerometer which will be similar in size/design to a watch. Participants are to wear the monitor for the duration of the study for a total of 6 days. It will record a number of activities during this time like sleep, steps taken, body position etc. Participants will be required to keep a diary at home, where they are to complete daily pain score assessments. Participants are to return to a scheduled clinic appointment on day 7 and return tri-accelerometer and diaries. Nil follow-up regarding the trial is required; participants will continue to see the doctor as per scheduled appointments. This research will help determine whether we may assess the effectiveness of pain management programs in an objective way. This in turn will allow us to determine which pain management methods are most effective.